Bioavailability and bioequivalence Flashcards
Bioavailability (BA) is a pharmacokinetic parameter that
A. Can be a measure of quality of a drug product, particularly the generic drugs
B. Is usually considered under the process of absorption
C. Is defined as the percentage of the active drug that enters the systemic circulation and its rate of entry
D. Is performed on certain drug products as benchmarked against the BA of the innovator drug and as required by the FDA now called Bioequivalence Test
E. AOTA
E
This is the most relevant parameter used to assess the extent of the bioavailability for a drug thru a particular route
A. Half-life
B. Cmax
C. Tmax
D. AUC0->t
D
Which is not included in an FDA application for approval of a generic drug?
A. Chemistry
B. Animal studies
C. Manufacturing
D. Bioequivalence
B
In bioequivalence studies, the following parameters are used to assess the bioavailability of the active ingredient
A. Half-life and Tmax
B. Tmax and AUCo->t
C. Cmax and Tmax
D. Cmax and AUC0->t
D
Which is incorrect
A. Rate of absorption depends on route of administration and drug formulation
B. Absolute bioavailability of 100 means that a drug is completely absorbed
C. Relative bioavailability is measured by comparing the respective AUCs after extravascular and intravascular administration
D. The oral formulation of propranolol that undergoes extensive first-pass metabolism must be administered in a much larger dose than the equivalent IV formulation of the same drug
C
Which of the ff. is incorrect?
A. Relative bioavailability is measured by obtaining the AUC of a drug’s IV form andextravascular form B. An orally administered drug, such as Propanolol, with an extensive 1st pass effect in the liver is absorbed less that its IV form C. The absorption of a drug starts in the stomach and small intestine and is dependent on dosage form and drug’s physicochemical properties D. An excessively hydrophobic drug such as Acyclovir is poorly absorbed
A
FDA bioavailability in vivo except:
A. Parenteral B. Capsules and tablets C. Oral solution D. Powder
B
Tablet - 100 ng 95.6
Solution 100 ng 93.3
IV 50 ng 38.2
Which of the following is true?
A. Absorbed in IV bolus if 50 ng B. Absolute bioavailability of oral tablet is 0.73. C. Relative bioavailability of oral tablet is 1.02. D. There is no need to conduct bioequivalence study for oral tablet to establish bioequivalence. E. AOTA
C
Cmax 88.7 98.7
AUC 0 - t 89.1 95.1
AUCt-∞ 98.1 121.1
Which of the following is true?
A. Pharmaceutical equivalent, bioequivalent B. Pharmaceutical equivalent, not bioequivalent C. Pharmaceutical alternative, bioequivalent D. Pharmaceutical alternative, not bioequivalent E. Pharmaceutical equivalent, therapeutic equivalent
*
For drug X, 120 grams of IV bolus was given. The computed Area Under the Curve (AUC) is 100 AUC units. The oral dose of 150 mg drug X produces 75 AUC units. What is the absolute oral bioavailability?
A. 25%
B. 30%
C. 50%
D. 60 %
D
Absolute bioavailability is determined when there are no intravenous data regarding a drug is available. T/F
F
Incomplete absorption and hepatic metabolism cause bioavailability of an oral drug to be less than 1. T/F
T
Therapeutically equivalent drugs have the following characteristics except
A. Same manufacturing processor, packaging, and expiration date
B. Same molar dose
C. Same effects
A
Relative bioavailability always compares a drug bioavailability to its intramuscular mode of administration. T/F
F
Relative bioavailability is the ratio of the bioavailability of a drug to a certain drug of reference, which means a value of 1 showed that this drug’s bioavailability is similar to the reference drug, which can have varying bioavailabilities (which may not be 100%). Not all reference drugs are IM.
The following statement is INCORRECT
A. Absolute bioavailability is measured by comparing the respective AUCs after extravascular and intravascular administration
B. The oral formulation of Propanolol that undergoes extensive first-pass metabolism must be administered in much larger doses than the equivalent IV formulation of the same drug
C. A relative bioavailability of 100 means that a drug is completely absorbed
D. The rate of absorption is determined by the route of administration and the drug formulation
C
